LKT200 Perfusion Circuit — Class II medical device recall Z-1437-2020
Terminated recall by Organ Recovery Systems, Inc., reported 2020-03-11, distributed nationwide. Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed
| Recall number | Z-1437-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Organ Recovery Systems, Inc., Itasca, IL, United States |
| Recall initiated | 2020-01-30 |
| Classified | 2020-03-04 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2021-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,274 |
| Reason classes | packaging |
| Lot numbers | 119648, 119765, 119944, 120055, 120242 |
Product
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.
Reason for recall
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1437-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.